Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

A Phase 3 study testing avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: avanafil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 712 participants
Where: 40 sitesUnited States
Study dates: Mar 2009to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
Agree to make at least 4 attempts at intercourse each month through the course of this study;
Agree not to use any other treatments for erectile dysfunction during participation in this study.
Provide written informed consent;
Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
Subjects requiring treatment with an excluded medication.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Research Site
Albany, New York, 12206
Research Site
Bala-Cynwyd, Pennsylvania, 19004
Research Site
Birmingham, Alabama, 35209
Research Site
Cary, North Carolina, 27518
Research Site
Charlotte, North Carolina, 28207
Research Site
Charlotte, North Carolina, 28209
Research Site
Clearwater, Florida, 33756
Research Site
Clearwater, Florida, 33761
Research Site
Cleveland, Ohio, 44122
Research Site
Coral Gables, Florida, 33134
Research Site
El Paso, Texas, 79935
Research Site
Harrisburg, North Carolina, 28075
Research Site
Hialeah, Florida, 33012
Research Site
Hickory, North Carolina, 28601
Research Site
Homewood, Alabama, 35209
Research Site
Houston, Texas, 77074
Research Site
Jacksonville, Florida, 32205
Research Site
Jupiter, Florida, 33458
Research Site
Kansas City, Missouri, 64114
Research Site
Lancaster, Pennsylvania, 17601
Research Site
Lawrenceville, New Jersey, 08648
Research Site
Madisonville, Kentucky, 42431
Research Site
New York, New York, 10016
Research Site
Ocala, Florida, 34471
Research Site
Pembroke Pines, Florida, 33024
Research Site
Ponte Vedra, Florida, 32081
Research Site
Raleigh, North Carolina, 27609
Research Site
Sacramento, California, 95821
Research Site
Salisbury, North Carolina, 28144
Research Site
San Diego, California, 92120
Research Site
San Diego, California, 92123
Research Site
Sandy Springs, Georgia, 30328
Research Site
Shreveport, Louisiana, 71106
Research Site
Spring, Texas, 77386
Research Site
Tampa, Florida, 33624
Research Site
Tucson, Arizona, 85712
Research Site
Waterbury, Connecticut, 06708
Research Site
Wichita, Kansas, 67205
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction

Conditions: Erectile Dysfunction
Being tested: avanafil
Keywords: ED, Erectile Dysfunction, Dysfunction, Erectile
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

avanafilDrug
Also called TA-1790, Stendra
All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.

Study groups in NCT00853606
Study group	Role	What they receive
avanafil	Experimental	Not described Receives: Drug: avanafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Measured: Baseline, 52 weeks
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Measured: Baseline, 52 weeks
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \& 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.
Measured: Baseline, End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Apr 2010

First posted2 Mar 2009 (estimated)
Study startMar 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 712 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853606
Sponsor's protocol ID: TA-314
Status last verified: Aug 2012
First submitted: 27 Feb 2009
Last updated: 17 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.
PubMed 23521325

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction

All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
ClinicalTrials.gov ID: NCT00853606
Acronym / sponsor ID: TA-314
Conditions: Erectile Dysfunction
Keywords: ED, Erectile Dysfunction, Dysfunction, Erectile
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 712 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 28 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
avanafil	Experimental	Drug: avanafil

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
Agree to make at least 4 attempts at intercourse each month through the course of this study;
Agree not to use any other treatments for erectile dysfunction during participation in this study.

Key exclusion criteria (2 listed)

Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
Subjects requiring treatment with an excluded medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
avanafilAlso: TA-1790, StendraAll subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.	Drug	avanafil

Primary outcome

Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
Time frame: Baseline, 52 weeks
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Time frame: Baseline, 52 weeks
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Time frame: Baseline, End of Treatment
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \& 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.

Results and safety

Results posted to the registry on 28 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Avanafil	712	492

Primary outcome: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.

Time frame: Baseline, 52 weeks. Mean (Standard Deviation). Unit: percentage of sexual attempts

Measure	Avanafil n = 686
Value	54.75 (35.915)

Population analysed: Number of participants analyzed represents the Intent-to-Treat population.

Primary outcome: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina

Time frame: Baseline, 52 weeks. Mean (Standard Deviation). Unit: percentage of sexual attempts

Measure	Avanafil n = 686
Value	36.91 (36.142)

Population analysed: Number of participants analyzed represents to Intent-to-Treat population.

Primary outcome: Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score

Time frame: Baseline, End of Treatment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Avanafil n = 686
Value	10.3 (7.88)

Population analysed: Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.

Adverse events

Time frame: AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Avanafil	11 of 712 (1.5%)	87 of 712 (12.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23521325Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.

Related trials for Erectile Dysfunction

Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew McCullough, MD principal investigator

NYU Urology Associates

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. (time frame: Baseline, 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.